|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080012 / PAS003 |
| Date Original Protocol Accepted |
05/04/2012
|
| Date Current Protocol Accepted |
05/04/2012
|
| Study Name |
Leachables Study
|
| Device Name |
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
|
| Clinical Trial Number(s) |
NCT00817596 NCT00866164
|
| General Study Protocol Parameters |
| Study Design |
Bench/Lab Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a non-clinical study.
|
| Study Population |
Not applicable. This is a bench/lab study.
|
| Sample Size |
8 Prometra pumps will be used in this study.
|
| Key Study Endpoints |
Leachables Testing
The leachables study will use eight (8) Prometra pumps as required in the condition of approval. The solutions will be placebo solutions at the appropriate corresponding pHs. At each time-point pumps will be emptied of their contents through the catheters and 15 mLs of solution will be used for leachable testing. Pumps will then be refilled with 22 mL of placebo solutions. This schedule mimics actual use of the pumps (dispensing and refilling) and will allow sufficient sample for the leachables testing.
Controlled Extraction Study
The control extraction studies will involve the evaluation of extraction solutions of the materials of the Prometra pumps that come into contact with the drug product formulation. The accelerated extractions will be done using an Accelerated Solvent Extraction. The solvents to be used for extraction are purified water, water adjusted to pH 9.5, isopropanol, and hexane. The materials of the pump will be extracted in each of these solvents at reflux for 24 hours.
|
| Follow-up Visits and Length of Follow-up |
Not applicable. This is a bench/lab study.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
N/A - Bench Study
|
| Actual Number of Sites Enrolled |
N/A - Bench Study
|
| Patient Follow-up Rate |
N/A - Bench Study
|
| Final Safety Findings |
All the test results met the acceptance criteria for Leachable and Extractables for all the time periods throughout the study.
|
| Final Effect Findings |
Effectiveness Results In all study reports test parameters in the test samples were not found to
be significantly different from previously tested time points.
|
| Study Strengths & Weaknesses |
The sponsor was consistent in their testing of trace metals, and where present, provided literature and rationale as to why their presence was not harmful. The sponsor should have communicated all protocol changes prior to implementation of such changes.
|
| Recommendations for Labeling Changes |
N/A
|
